January 2022 FDA Recall Polymyxin B by Auromedics Pharma Llc
D-0556-2022 - Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

This Class I drug recall was voluntarily initiated by Auromedics Pharma Llc on January 26, 2022 for the product Polymyxin B. The FDA reported the reason for recall as presence of particulate matter; product complaint of hair discovered in a vial within the lot. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0556-2022

Reason for Recall
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Initiated
01-26-2022
Reported
02-16-2022
Quantity
35,520 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-20-2024
Product Description About Product Description
Full technical description of the product.
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

Batch or Lot Expiration Information

Lot# Lot CPB200013, exp 9/2022

Affected Packages Involved in this Recall

55150-234-10 Polymyxin B